A 24-weeks, Multi-center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride in Chinese Subjects With Severe Alzheimer's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

260 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2014-09-30

Brief Summary

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The objective is to demonstrate that donepezil hydrochloride 10 mg/day has superior efficacy compared with placebo in cognitive function in Chinese subjects with severe Alzheimer's Disease.

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Detailed Description

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Conditions

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Alzheimer's Type Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Group Type EXPERIMENTAL

E2020

Intervention Type DRUG

In titration period, donepezil 5-mg tablet will be taken orally once daily for 6 weeks, following donepezil 10 mg tablets taken orally once daily for 18 weeks in the maintenance period.

2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo matched to donepezil 5 mg or 10 mg tablets taken orally once daily for 24 weeks.

Interventions

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E2020

In titration period, donepezil 5-mg tablet will be taken orally once daily for 6 weeks, following donepezil 10 mg tablets taken orally once daily for 18 weeks in the maintenance period.

Intervention Type DRUG

Placebo

Placebo matched to donepezil 5 mg or 10 mg tablets taken orally once daily for 24 weeks.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Written informed consent (IC) will be obtained from the subject (if possible) or from the subject's legal guardian or legal representative prior to beginning screening activities.
* Subject age range: male and female subjects 50 to 90 years of age, inclusive
* Diagnosis: diagnostic evidence of probable Alzheimer's Disease (AD) consistent with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
* MMSE 1 to 12 inclusive, at both Screening and Baseline
* SIB less than or equal to 90 and greater than or equal to 10 at both Screening and Baseline
* Comorbid medical conditions must be clinically stable prior to Baseline, unless otherwise specified.

Exclusion Criteria

* Subjects with a known history of disorders that affect cognition or the ability to assess cognition, but are distinguishable from AD
* Evidence of focal disease to account for dementia on any cranial image MRI or CT.
* Subjects with dementia complicated by other organic disease or AD with delirium according to DSM-IV criteria
* Subjects who cannot swallow or who have difficulty swallowing whole tablets, as tablets should not be broken or crushed
* Illiteracy prior to AD
* Subjects who are unwilling or unable to fulfill the requirements of the study
* Treatment with another cholinesterase inhibitor and/or memantine in the 3 months prior to Screening
* Subjects with a poor response (tolerability) to prior exposure to donepezil

Minimum Eligible Age

50 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Naoki Kubota

Role: STUDY_DIRECTOR

Neuroscience Clinical Development Section, Japan/Asia Clinical Research Product Creation Unit, Eisai Co., Ltd.

Locations

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